Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

This study was conducted within the Section of Family Planning in the Department of Obstetrics and Gynecology at The University of Chicago and within the Department of Family Medicine at the University of Illinois-Chicago. From December 2007 through June 2008, 37 adolescent females were approached regarding the study.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

All of the 23 enrolled subjects were ultimately randomized to the treatment arms (12 to LNG-IUS and 11 to CuT380A).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Paragard IUD [CuT380A]

Paragard intrauterine device (IUD), Copper T 380A

Mirena IUD [LNG-IUS]

Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System

Total

Total of all reporting groups

Baseline Measures

Paragard IUD [CuT380A]

Mirena IUD [LNG-IUS]

Total

Number of Participants
[units: participants]

11

12

23

Age
[units: years]Median ( Full Range )

17
( 15 to 18 )

16.5
( 14 to 18 )

16.5
( 14 to 18 )

Gender
[units: participants]

Female

11

12

23

Male

0

0

0

Ethnicity (NIH/OMB)
[units: participants]

Hispanic or Latino

1

1

2

Not Hispanic or Latino

10

11

21

Unknown or Not Reported

0

0

0

Race (NIH/OMB)
[units: participants]

American Indian or Alaska Native

0

0

0

Asian

1

0

1

Native Hawaiian or Other Pacific Islander

0

0

0

Black or African American

6

9

15

White

4

2

6

More than one race

0

1

1

Unknown or Not Reported

0

0

0

Education
[units: participants]

8th grade or less

0

1

1

Current high school student

8

10

18

High school diploma/GED

2

0

2

Some college/current college student

1

1

2

Parous
[1][units: participants]

Parous

7

4

11

Nulliparous

4

8

12

Previous STI
[2][units: participants]

Yes

4

2

6

No

7

10

17

Presence of STI at screening visit
[3][units: participants]

Yes

1

3

4

No

10

9

19

[1]

A parous female participant has given birth one or more times. A female is nulliparous if she has never given birth.

[2]

Number of participants who have previously tested positive for one or more of the following sexually transmitted infections (STI) during the screening visit: chlamydia, gonorrhea, trichomonas, and vaginal warts.

[3]

Number of participants who tested positive for one or more of the following sexually transmitted infections (STI) during the screening visit: chlamydia, gonorrhea, trichomonas, and vaginal warts.

Rates of participants experiencing heavy bleeding among teens randomized to the LNG-IUS or Copper T 380A.

Time Frame

6 months

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All study participants were included in the analysis.

Reporting Groups

Description

Paragard IUD [CuT380A]

Paragard intrauterine device (IUD), Copper T 380A

Mirena IUD [LNG-IUS]

Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System

Measured Values

Paragard IUD [CuT380A]

Mirena IUD [LNG-IUS]

Number of Participants Analyzed
[units: participants]

11

12

Heavy Bleeding Rates
[units: percentage of randomized subjects]

55

33

Statistical Analysis 1 for Heavy Bleeding Rates

Groups [1]

All groups

Method [2]

Fisher Exact

P Value [3]

0.4136

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced heavy bleeding. Under the null hypothesis, heavy bleeding rates are similar for both IUD types.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

Two-sided test

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

Rates of partial or complete expulsion for teens randomized to the LNG-IUS or Copper T 380A. Patients experiencing partial expulsion had IUDs visible on speculum exam. Complete expulsion is characterized by complete evacuation of the IUD.

Time Frame

6 months

Safety Issue

Yes

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

All study participants were included in the analysis.

Reporting Groups

Description

Paragard IUD [CuT380A]

Paragard intrauterine device (IUD), Copper T 380A

Mirena IUD [LNG-IUS]

Mirena intrauterine device (IUD), Levonorgestrel Intrauterine System

Measured Values

Paragard IUD [CuT380A]

Mirena IUD [LNG-IUS]

Number of Participants Analyzed
[units: participants]

11

12

Expulsion Rates
[units: percentage of randomized subjects]

18

0

Statistical Analysis 1 for Expulsion Rates

Groups [1]

All groups

Method [2]

Fisher Exact

P Value [3]

0.2174

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Fisher's exact test was used to examine the significance of the association between IUD type (Paragard or Mirena) and whether or not the subject experienced expulsion of the IUD. Under the null hypothesis, expulsion rates are similar for both IUD types.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

Two-sided test

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: